Note: Descriptions are shown in the official language in which they were submitted.
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LOCKABLE CONTAINER WITH INNER TRAY
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims priority to co-pending U.S. Provisional
application
60/520,143, filed on November 13, 2003. The entire disclosure of that prior
filed application is
hereby incorporated by reference.
FIELD OF THE INVENTION
[0002] This invention relates to a package that houses portable items on a
tray configured
to be inserted into an outer sleeve. This package may have one or more
internal or external locks
that prevent the tray from being pulled out of the sleeve. This package
provides a child-resistant,
senior-friendly package that can be opened and closed numerous times to access
the items
held by the tray.
BACKGROUND OF THE INVENTION
[0003] Conventional pharmaceutical packaging has shortcomings with regard to
drug
delivery devices, which create problems for both the manufacturer and end
user. For example, it
is known to distribute syringes, vials, inhalers, patches, test kits, or parts
thereof in packaging that
incorporates foam elements to separate and pad the product. Such conventional
packaging
normally holds the product in a vertical position; however, where conventional
packaging holds the
product in a horizontal position, the products are typically layered on top of
each other. It is also
known to distribute drug delivery devices loose - or loose, but individually
wrapped - in
conventional boxes without any means for holding or protecting the products.
[0004] The conventional manufacturer that incorporates form or plastic
elements in its
packaging to protect the product carries an increased inventory and employs a
more complicated
manufacturing system to produce its packaging. Further, the conventional
manufacturer typically
produces one kind of package to be filled by automated means and another kind
to be filled by
hand, which also increases inventory and the number of product lines.
[0005] Conventional manufacturers of drug delivery device packaging typically
do not
provide a child-resistant feature to prevent unauthorized access, or a
stopping feature to prevent
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accidental spillage. Where these features do exist, they exist at the expense
of easy access for
the end user with limited dexterity. Neither does the known drug delivery
device packaging
provide ample space to place appropriately sized graphics, such as dose
compliance instruction
and warnings, for the end user with limited sight.
[0006] In addition, conventional manufacturers pack drug delivery devices
tightly and in
the most efficient manner possible - from the perspective of shipping cost
savings - but, again, at
the expense of the end user who has limited physical mobility, such as an end
user with arthritis of
the hands and fingers. Also conventional manufacturers are known to distribute
only wholly-
assembled drug delivery devices together, or parts of devices together, but
not whole devices and
parts together. For example, it is known to distribute syringes together or
vials together on the
same platform, but not syringes and vials together on the same platform.
[0007] End users are familiar with the disposal problems created by the use of
drug
delivery devices. Typically, spent patches, vials, needles, inhalers,
syringes, barrels, and other
devices or parts thereof should be sealed or otherwise protected in order to
be disposed of safely.
While it is known to dispose of syringes and needles in a separate device,
such as a sealed plastic
container, there remains a need for a drug delivery device packaging that also
serves as a safe
means of disposal.
[0008] It is apparent from a survey of the packaging arts that there exists a
need for an
apparatus that holds and protects all types of drug delivery devices and parts
thereof, allows for
improved manufacturing process, includes child-resistant and spill-prevention
features, stores a
variety of objects in response to the end users' needs, is fitted for easy
access by the end user
with limited dexterity, has sufficient area to receive graphics, and provides
a means for safe
disposal.
SUMMARY OF THE INVENTION
[0009] The present invention fulfills the needs identified above by providing
packaging
comprising an inner slide card/tray that is inserted within an outer sleeve.
In some
embodiments, the outer sleeve and inner slide card/tray both comprise elements
configured to
cooperatively engage the other to create a means for locking, means for
releasing, and means
for stopping.
[00010] In exemplary embodiments, the means for engaging include panels, tabs,
catches, ribs, catches, abutments, edges, cutouts, apertures, and like
elements, integral to or
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attached to either the card or tray, configured to connect with similar
elements associated with
the outer sleeve, and referred to herein as the means for locking. The means
for releasing
include panels, tabs, ribs, abutments, edges, cutouts, catches, apertures, and
like elements,
integral to or attached to the outer sleeve, configured to uncouple engaged or
locked elements.
Thus, the present invention provides an optional child-resistant feature. A
means for stopping
comprise panels, tabs, ribs, catches, abutments, apertures, edges, cutouts,
and like elements,
integral to or attached to either the card or tray, configured to matingly
engage similar elements
associated with the outer sleeve. Thus, the present invention provides an
optional spill-resistant
feature to prevent the user from pulling the tray completely away from the
outer sleeve.
[00011] Alternative embodiments include an apparatus and method for holding
and
storing drug delivery devices by providing an inner tray configuration that,
by way of example
and not limitation, protects a plunger from inadvertent activation; shields a
needle from
inadvertent exposure; allows easy access to a drug-filled container for
removal and
replacement; and collects and stores the spent devices. Accordingly,
embodiments of the
present invention provide an apparatus and system that is able to safely ship
drug delivery
devices for trans-epidermal, oral, or hypodermic administration, including pre-
filled syringes,
needles, vials, ampoules, protective shields, patches, inhalers, and parts
thereof, and like
devices, safely store the unused devices, and safely store the used devices
until all can be
safely disposed as unit.
[00012] Embodiments include a pre-formed tray attached to a paperboard card,
and a monolithically formed card/tray combination. Compliance information or
general
information related to the medication or therapy may be positioned on or with
the slide card,
tray, or outer sleeve in a manner easily visible by the user. In one
embodiment, indicia -- such
as, but not limited to, time of day, days of the week, numerical sequence, or
dosage amounts --
are positioned adjacent to the devices.
[00013] Another embodiment of the present invention comprises a slide card
with an
engaging tab and a tray receiving area. At least one pre-formed tray,
configured to receive and
hold at least one portable item, may be attached to the tray receiving area.
An outer sleeve
that receives the card and attached tray comprises a locking edge configured
to engage the tab
at a locking position. The outer sleeve also has an integral release
configured to disengage the
tab from the locking position. Yet another embodiment of the present invention
includes a slide
card constructed of one material, with a base panel and a tray receiving area
located on the
base panel. A pre-formed tray constructed of a different material, with at
least one receiving
recess, is attached to the card at the tray receiving area. Both may be fully
inserted within a
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void defined by an outer sleeve, through an open end of the sleeve. Another
embodiment of
the present invention is defined by a slide card and outer sleeve combination.
Here the side
card comprises a means for engaging and at least one tray receiving area,
together with a pre-
formed tray configured to receive and hold at least one portable item,
attached to the tray
receiving area. Here the outer sleeve defines a void configured to receive the
card and
attached tray, and comprises a means for locking the card's means for
engaging. The outer
sleeve also includes an integral means for releasing configured to uncouple
the means for
engaging from the means for locking.
[00014] Other embodiments of the present invention include improved
components,
such as a monolithically fabricated tray with card. Here, a tray with card may
be fabricated from
any forming technique or process known to those skilled in the art, including
but not limited to
thermo-forming, vacuum forming, and injection molding. The tray with card
includes an
engaging panel hingedly attached to a second panel or the integral tray. The
tray comprises at
least one recess configured to receive and hold a portable item. A third
panel, configured to
fold over and cover the items) in the tray, may likewise be hingedly attached
to either the
second panel or tray. This improved component is configured to be inserted
into an outer
sleeve.
[00015] In practice, some embodiments of the present invention are configured
to
resist access to an item by securing the item in a lockable package. A method
for resisting
access to an item secured in an embodiment of the present invention comprises
the following
steps, presented in the following order for the purposes of teaching and not
limitation. Provide
a slide card with a means for engagement and a base panel. Attach a pre-formed
tray
comprising at least one receiving recess to the base panel and place an item
in the. recess.
Provide an outer sleeve with an open end, an accessible void, and a means for
locking the
card. Align the card with the open end and orientate the means for engagement
with the
means for locking. Insert the card fully into the void to cause the means for
engaging and
means for locking to releaseably couple or connect.
[00016] Embodiments according to this invention offer at least the following
advantages: lightness in weight, resistance to tampering, child-resistance,
ease of access,
excellent durability, ease of assembly, device protection, ease of storage,
ease of disposal, the
ability to present devices of different and unusual shapes, and excellent
economy.
[00017] It is also contemplated that the present invention is not limited to
pharmaceutical-related goods, but is applicable to a plethora of delicate,
sensitive, or unique
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portable goods. Small electronic components, jewelry, foods, expensive and
precious articles,
and any other item that requires a safe, stable, and portable environment in
which to be
shipped and stored may find an application with the present invention. Other
advantages of the
present invention will be apparent from the following description, the
accompanying drawings,
and the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[00018] FIG. 1 is a plan view of an embodiment of a slide card blank;
[00019] FIG. 2 is a plan view of an embodiment of a pre-formed tray;
[00020] FIG. 3 is a plan view of an alternative embodiment of a pre-formed
tray;
[00021] FIG. 4 is a plan view of an embodiment of an outer sleeve blank;
[00022] FIG. 5 is an isometric view of a completely constructed embodiment of
the
present invention.
DETAILED DESCRIPTION OF THE INVENTION
[00023] As required, detailed embodiments of the present invention are
disclosed
herein. It will be understood that the disclosed embodiments are merely
exemplary of the
invention that may be embodied in various and alternative forms. The figures
are not
necessarily to scale, and some features may be exaggerated or minimized to
show details of
particular components. In other instances, well-known materials or methods
have not been
described in detail in order to avoid obscuring the present invention.
Therefore, specific
structural and functional details disclosed herein are not to be interpreted
as limiting, but as a
basis for the claims and for teaching one skilled in the art to variously
employ the present
invention.
[00024] Referring now to the drawings, wherein like numerals represent like
features
throughout, there are illustrated embodiments of the present invention.
Turning first to FIG. 1
and FIG 2, there is shown an internal slide card 10 and slide card tray 12. As
shown, the slide
card 10 is configured to connectedly receive the tray 12 at a tray receiving
area 14 and the
tray 12 is configured to receive and store an item, such as a drug delivery
device.
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[00025] Herein, the phrase "drug delivery devices" is used broadly to refer to
all
apparatus and parts thereof used in conjunction with transferring substances
into or out of a
body, such as but not limited to a human being. By way of example and not
limitation, a drug
delivery device comprises a substance in the form of, or contained within,
pills, tablets,
chewables, aerosols, inhalers, trans-dermal patches, suppositories, injectable
devices, parts
thereof, and the like. Injectable devices comprise a plunger, barrel, and
needle used by a
medical professional to treat a patient with a pharmaceutical drug, or the
patient to treat him or
herself. For purposes of teaching and not limitation, the illustrated tray
embodiments are
directed to drug delivery devices in the form of injectable devices, but those
skilled in the art
will immediately understand that the tray may be configured to hold any
portable item.
[00026] As best shown in FIG. 1, the illustrated card 10 includes a base panel
16,
spine panel 18, top panel 20 and tab 22. The respective panels are defined by
fold-lines 24a,
b. Depending upon the material used to construct the card, fold-lines are
formed by scores,
cuts, bends, perforations, live hinges, formed hinges, and the like. As
described in detail below,
tab 22 may function as part of a means for locking and/or as part of a means
for stopping by
cooperatively engaging with a first element to create a child-resistant
feature or cooperatively
engaging with a second element to create a spill-resistant feature.
[00027] With regard to choice of materials, the slide card 10 may comprise
paper,
paperboard, cardboard, plastic, or combinations thereof. Where the slide card
10 comprises
paperboard, bleached sulphate, solid unbleached sulphate, or clay-coated
newsback are well-
known design choices. Typically the paperboard coating is a fluid blend of
materials, such as
coating clay, calcium carbonate, and/or titanium dioxide with starch or
adhesive smoothly
applied to the traveling surface. Successive densification and polishing
finish the mineral-
coated surface to a superior, graphic-print surface. When the card and/or tray
is paper,
fabrication techniques well known to those skilled in the art, including
vacuum forming, are
contemplated. When the card and/or tray is plastic, fabrication techniques
well known to those
skilled in the art, including thermo-forming, injection molding, and the like,
are contemplated.
Where the slide card 10 is plastic, the fold-lines 24a, b may be live hinges,
or, as explained
below regarding the engaging feature of the tab 22, fold-line 24b may be a
formed hinge with
an upwardly or downwardly extending profile to create an internal spring
tension that urges the
tab 22 back toward a relatively relaxed or horizontal orientation when the tab
22 is first folded
over toward base panel 16.
[00028] FIG. 2 and FIG. 3 show two possible alternative embodiments of pre-
formed
trays 12, 26. Here, both trays 12, 26 are constructed of plastic, in the
manner well known by
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those skilled in the art, and are configured to receive and hold various items
of various shapes.
Also, as understood by those skilled in the art, both the exterior and
interior tray configurations
are merely design choices. Here, for purposes of teaching and not limitation,
the exterior of the
illustrated trays 12, 26 are configured to be affixed to and within the tray
receiving area 14 (best
shown in FIG. 1), while the interior of the illustrated trays 12, 26 are
configured to receive and
store drug delivery devices. One drug delivery device illustrated is a vial 30
for holding a
medicament in liquid form and another is a syringe 32 to be used in
conjunction with the vial 30.
[00029] The tray 26 is configured to receive and store items of substantially
uniform
shape and size, such as the illustrated syringe 32 comprising a plunger 34,
barrel 36, finger
guard 38, and needle 40. The tray 26 comprises a means for securing and
holding the syringe
32, such as the plunger-receiving recess 42, barrel-receiving recess 44, and
needle-receiving
recess 46. The recesses 42, 44, 46 may be configured to lock in or otherwise
secure the item
by including a means for resisting removal such as fold-over locking flaps,
indentions, straps,
inserts, and the like (not shown). Accordingly, a means for holding and
storing a drug delivery
device includes a pre-formed tray that can be configured in a variety of ways.
[00030] Regarding the illustrated embodiments, in practice the tray 12, 26 is
pre-
formed separately and then affixed to the card 10 at the tray receiving area
14, the location
being merely a design choice. An alternative embodiment, that, is not
illustrated comprises a
monolithically formed card/tray combination. There it is contemplated that the
slide card 10 is
an integral part of the tray 12, 26, the two components being formed as a
single unit during
fabrication.
[00031] The tray 12 is configured to receive and store items of substantially
unique
shapes and sizes, such as the vial 30 and syringe 32. Thus, tray 12 comprises
a means for
securing and holding the vial 30, such as the vial-receiving recess 48, and a
means for securing
and holding the syringe 32 as described immediately above. The recess 48 may
be configured
to lock in or otherwise secure the item by including a means for resisting
removal such as fold-
over locking flaps, indentions, straps, inserts, and the like (not shown). As
understood by one
skilled in the art, the various recesses illustrated herein may be configured
to receive and store
any portable items of any shape or size.
[00032] Here the trays 12, 26 are also configured to allow for easy access to
the
items. By way of illustration and not limitation, the devices are arranged so
that the end user,
who may have limited physical mobility such as arthritis, can retrieve one
device without
affecting another. As illustrated, orienting the widest portion of the syringe
32 -- in this
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example, the finger guard 38 -- to take the most space to provide the greatest
accessibility is a
desirable feature of this embodiment. Such horizontal orienting also provides
easy viewing of
the devices so the user may easily distinguish between them. Further, such
orienting provides
ample area to receive graphics. For example, dosage regimen instructions
including date, day,
and time may be formed on the tray sections between or adjacent to the
recesses.
Alternatively, the items held on the tray may be as closely packed and aligned
as desired.
[00033] Patient and healthcare provider information, such as dose compliance,
warnings, and instructions in written form or digital form can be made easily
visible or
accessible to the user through the ample billboard space found on either side
of the panels 16,
20, tab 22, or the components described below.
[00034] Turning now to FIG. 4 and FIG. 5, there is shown an outer sleeve 100
for
receiving an inner card 10 with tray 12, 26, and the related outer sleeve
blank 102. As best
shown in FIG. 4, the illustrated blank 102 includes side panels 104,106, 108,
spine panels 110,
end panels 116, 118 and extension panel 120. The panels 104, 106, 108 are
defined by the
respective adjacent fold-lines 124a, b and the respective outer edges 126.
[00035] Side panel 104 comprises release button 130, defined by release button
cut
132 and release button fold-line 134. Side panel 108 comprises a first
engaging tab cutout 140
defined by cut-line 142, and a second engaging tab cutout 144 defined by cut-
line 146. Side
panels 104 and 106 further comprise access cutouts 148. As explained below,
first engaging
tab cutout 140 and engaging tab 22 together form an embodiment of a means for
locking, while
second engaging tab cutout 144 and engaging tab 22 together form an embodiment
of a means
for stopping.
[00036] With regard to assembly, the blank 102 is folded and connected using
conventional techniques to create the outer sleeve 100, best shown in FIG. 5
as a slip case
defining a void 150. One sequence of folding and connecting the blank 102 is
as follows, with
reference to the visible side of the illustrated blank 102 as the face and the
opposite side as the
back. Extension panel 120 is folded back along transverse fold-line 124b. Side
panel 108 is
then folded along longitudinal fold-lines 124a under the side panels 106, 104
and positioned
under panel 104 so that the face of panel 108 may be affixed to the back of
panel 104. In this
embodiment, panel 108 is affixed to panel 104 so that the first engaging tab
cutout 140 is
immediately under the release button 130. In other words, in the illustrated
embodiment the
release button 130 is unobstructed by any solid surface of panel 108. End
panels 116, 118 are
folded inwardly so that the face of one end panel may be affixed to the back
of the other.
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[00037] Generally speaking, items are placed within inner tray 12, 26 and then
the
combined card 10 and tray 12, 26 is inserted into the void 150 of outer sleeve
100. In the
example of drug delivery devices holding unit doses, the illustrated Unit Dose
Packaging
System (UDPS) secures these devices until they are retrieved for use. In
practice, items are
placed within the inner tray 12, 26 and then the various panels and tabs are
folded before the
combined card 10 and tray 12, 26 is inserted into the outer sleeve 100. For
purposes of
teaching and not limitation, the following folding sequence is described. Top
panel 20 is folded
so as to cover the tray 12, 26 and orient the spine panel 18 adjacent to a
side of the tray. Tab
22 is folded inwardly so that the face of tab 22 is proximate to the face of
base panel 16. With
the card 10 folded as described, the combined card 10 and tray 12, 26 is
inserted into the void
150 of outer sleeve 100 through the open end, starting with the edge formed by
fold-line 24b
and with the tab 22 receivingly aligned with release button 130, as
illustrated in FIG. 5. The
card 10 with inner tray 12, 26 is then fully inserted into the outer sleeve
100, to a fully closed
position.
[00038] With continued reference to FIG. 5, and as understood by those skilled
in the
art, spring tension created by the inwardly folded tab 22 causes the tab edge
154 to contact the
interior side of panel 108. Two particular points of contact along the
interior side will be noted.
From the fully closed position, the engagement of tab edge 154 with the
internal edge 156 of
cutout 140 at the locking position A provides a child-resistant feature. From
a fully opened
position, the engagement of the tab edge 154 with the interior of the folded
extension panel 120
at the stopping position B provides a spill-resistant feature. The cutout 144
may be shaped to
efficiently engage tab edge 154. As illustrated, cutout 144 provides a semi-
circular concave
profile when panel 120 is folded, which engages well with the semi-circular
convex profile of tab
edge 154. As understood by those skilled in the art, these engaging profile
shapes are merely
a design choice and not a limitation of the present invention. It will be
understood that an
embodiment of the UDPS may be constructed without either or ,both of the child-
resistant or
spill-resistant features.
[00039] In the illustrated embodiment the locking feature includes the release
button
130, cutout 140, and cooperatively engaging tab 22. The spring tension created
by the folded
tab 22 causes the tab edge 154 to engage the internal edge 156 of cutout 140.
With the tab 22
and internal edge 156 engaged, the inner tray 12, 26 is locked within the
outer sleeve 100 and
cannot be accessed. This means for locking creates a child-resistant feature.
As illustrated,
internal edge 156 has a semi-circular convex profile that engages well with
the semi-circular
convex profile of tab edge 154. To unlock the child-resistant feature of this
embodiment and
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thereby access the tray 12, 26, the user depresses the release button 130,
which in turn
depresses the tab 22 to disengage the tab edge 154 from the internal edge 156.
[00040] After releasing the optional child-resistant.feature the inner card 10
may be
extracted from the outer sleeve 100 to a fully open position. In the
illustrated embodiments, a
fully open position occurs when tab 22 engages the interior of folded
extension panel 120 at
stopping position B. As will be understood by those skilled in the art, the
spring tension created
by the folded tab 22 causes the tab 22 to engage the folded interior of the
extension panel 120.
Once engaged, the card 10 cannot be further removed from the outer sleeve 100
but may be
re-inserted to a fully closed position if desired. In this manner, tab 22 acts
as a spill-resistant
feature to prevent inner card 10 from being pulled completely out of sleeve
100.
[00041] It will be understood that a means for locking and a means for
stopping are
contemplated in various embodiments. For example, in the illustrated
embodiment the
extension panel 120 is not attached to side panel 108, but is allowed to
extend downwardly into
the void 150 to catch and engage the folded tab 22 as the card 10 is removed
from the sleeve
100, thereby forming a means for stopping. In an alternative embodiment the
extension panel
120 is folded inwardly and the respective backs of the panels 120, 108 are
attached so that the
extension panel edge 152 abuts tab edge 154, thereby forming a means for
stopping. In the
illustrated embodiment the first cutout 140 and the engaging tab 22 have a
similar profile, which
facilitates engagement of the respective edges 154, 156 and forms a means for
locking. In
alternative embodiments any edge or protrusion within the void 150 configured
from panels,
tabs, cutouts, ribs, offsets, catches, apertures, abutments, edges, and like
elements, that
engage the tab 22 or tab edge 154, forms an alternative means for locking or
an alternative
means for stopping. In yet another embodiment, tab 22 or edge 154 is connected
to the tray
12, 26 to create a means for locking and a means for stopping.
[00042] The user may open and close the UDPS by withdrawing and replacing the
inner tray 12, 26 within the outer sleeve 100 as often as desired. Regarding
the illustrated
embodiments, from the fully closed position the user grasps the card 10 at the
top panel 20 and
bottom panel 16, adjacent to the spine panel 18, from the access cutouts 148
provided in side
panels 104, 106. The user then depresses the release button 130 in order to
disengage the
means for locking. Continuing to depress the button 130 while grasping and
pulling laterally the
card/tray will withdraw the tray 12, 26 from the sleeve 100. From the fully
open position the user
may fold back the optional top panel 20 to access an item held in the tray 12,
26. After
accessing the desired item, the user folds the top panel 20 back over the tray
12, 26 and
reinserts the card 10 within the sleeve 100 for future use.
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[00043] An alternative embodiment (not shown) designed to be disposed of
together
with spent drug delivery devices, may be placed within a labeled plastic bag
provided with the
USPS thereby giving notice of its contents. By way of illustration and not
limitation, additional
means for protecting and sealing an embodiment that holds spent drug delivery
devices until
they can be disposed of together, include sealable bags, a self-sealing outer
sleeve, a sealable
outer sleeve large enough to receive the sleeve 100. Similarly, taping the
inner tray within the
sleeve with a labeled tape giving notice of the contents is a means for
protecting and securing.
[00044] It is contemplated that the present invention is not limited to the
pharmaceutical-related goods illustrated, but is applicable to a plethora of
delicate, sensitive, or
unique portable goods. By way of example and not limitation, small electronic
components,
jewelry, foods, expensive and precious articles, and any other item that
requires a safe, stable,
and portable environment in which to be shipped and stored may find an
application with the
present invention. Further, it will be understood that variations,
modifications, and
enhancements can be made to the disclosed apparatus and methods without
departing from
the scope of the present invention as defined in the following claims.
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